A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: ReShape Duo balloon; Other: Diet counseling; Other: Exercise counseling

• Registration Number: NCT01673698
• Lead Sponsor: ReShape Lifesciences

Brief Summary

The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Disposition First Submitted: 2014-10-02
• Disposition First Submitted QC: 2014-10-02
• Disposition First Posted: 2014-10-09
• Results First Submitted: 2015-08-25
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-02
• Last Update Submitted: 2015-11-02
• Results First Posted: 2015-12-07
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReShape Duo Balloon	Diet counseling	ReShape Duo Balloon
ReShape Duo Balloon	Exercise counseling	ReShape Duo Balloon
Sham Comparator	Diet counseling	Sham Comparator
ReShape Duo Balloon	ReShape Duo balloon	ReShape Duo Balloon
Sham Comparator	Exercise counseling	Sham Comparator

Primary Outcome Measures

Name	Time	Method
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24	Week 24	An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Treatment Group Responder Rate Dichotomized at 25% EWL	24 weeks	An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.

Secondary Outcome Measures

Name	Time	Method
Weight Loss Maintenance Six Months Following Device Removal	48 weeks	Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.

Trial Locations

Locations (8)

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States

Hamilton Medical Center; 🇺🇸 Dalton, Georgia, United States

Marquette General Surgical Weight Loss Center; 🇺🇸 Marquette, Michigan, United States

Greenville Hospital System; 🇺🇸 Simpsonville, South Carolina, United States

University of TX Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Midsouth Bariatrics; 🇺🇸 Memphis, Tennessee, United States

University of Minnesota/Department of Gastrointestinal Surgery; 🇺🇸 Minneapolis, Minnesota, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States